MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY

Model Number 295025-001

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom onboard battery will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom onboard battery showed full charge but the freedom driver exhibited an alarm when the battery was inserted.There was no reported adverse patient impact.

Manufacturer Narrative

The battery leds would not display a full charge when the fuel guage button was depressed.Additionally, when the battery was connected to the software interface it was determined that the battery could not communicate, receive a charge, or discharge its cells.The battery was inserted into a freedom driver and the battery would not power the driver; with the driver plugged in to wall power and a known functioning battery installed, the customer returned battery was installed and the driver alarmed as it is designed.This confirmed the customer-reported issue.The root cause of the battery's inability to charge or discharge was caused by unrecoverable discharge of the cells resulting in the battery being unable to communicate serially and initiate charging.Syncardia has a corrective and preventive action (capa) to address the inability of the user being able to detect when a freedom onboard battery is disabled.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 10846292
• MDR Text Key: 219336057
• Report Number: 3003761017-2020-00230
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003084
• UDI-Public: (01)00858000003084
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 295025-001
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR